Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT06644118
Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of multiple myeloma according to the 2014 IMWG diagnostic criteria
* Relapsed/refractory multiple myeloma as defined by:
1\) Received at least 3 prior lines of MM treatment (must include a PI, an IMiD, and an anti-CD38 antibody).
2）Disease progression within 12 months of the most recent anti-MM therapy; or disease progression within the past 6 months and subsequently lack response to the most recent line of therapy.
* Measurable disease at screening as defined by any of the following:
1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
2. Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
* Positive expression of either BCMA or GPRC5D on bone marrow plasma cells; must be GPRC5D expression positive if previously received BCMA targeted therapy
* ECOG 0-1
* Expected life expectancy exceeds 12 weeks
* Adequate bone marrow reserve or organ function meeting the following criteria:
1. Hemoglobin ≥ 70 g/L
2. Platelet count ≥ 50 × 10\^9/L
3. Absolute lymphocyte count ≥ 0.3×10\^9/L
4. Absolute neutrophil count ≥ 1.0 × 10\^9/L
5. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN)
6. Total bilirubin ≤ 2 times ULN; except in subjects with congenital bilirubinemia (such as Gilbert syndrome, in which case the direct bilirubin ≤1.5 × ULN is required)
7. Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault equation).
8. corrected serum calcium ≤12.5 mg/dL (≤3.1 mmol/L) or free ionized calcium ≤6.5 mg/dl (≤1.6 mmol/L)
9. SpO2\>92% on room air
10. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram; no clinically meaningful pericardial effusion by ultrasound
Exclusion Criteria:
* Solitary plasmacytoma
* Known active central nervous system (CNS) involvement or exhibits clinical signs of CNS involvement of multiple myeloma.
* Received allogeneic stem cell transplant; received autologous stem cell transplant within 12 weeks before screening
* Active second primary malignant tumor, exclude the following: cured non- melanoma skin cancer, non-metastatic prostate cancer, cervical carcinoma in situ, ductal or lobular carcinoma in situ of the breast
* Any other significant medical disease, abnormality, or condition that, in the investigator judgment, may make the patient unsuitable for participation in the study or put the patient at risk.
* Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06644118
Study Brief:
Protocol Section:
NCT06644118